Around 200 patients contacted after chemotherapy drug recall

Around 200 patients have been contacted after a number of batches of chemotherapy drugs were recalled, the HSE has stated this afternoon.

The HSE was notified this week of the precautionary recall of the drugs, which were manufactured between September 29 and October 12.

The Health Product Recall Authority (HPRA), the body with overall responsibility for overseeing recall activity, said that the implicated products, manufactured by Fannin Compounding Limited (FCL), are mainly patient specific therapies produced to order for both public and private hospitals.

According to the HSE, the company stated that a potential drug sterility issue was detected during routine daily tests that occur as part of their quality assurance processes. There is no indication from the company at this time that any drug has been affected.

“However, on a precautionary basis, it was decided that those patients who received the drugs should be contacted by their treating hospitals, made aware of the situation and offered appointments to meet with their clinical teams to discuss any possible concerns,” the HSE stated.

“All patients involved have now been contacted and offered an appointment.

“However, if in the interim, any of these patients experience any unexpected symptoms differing from what they normally experience after treatment, they are being advised to attend at or/and contact their treating hospital.

“The HSE would like to apologise to our patients for any anxiety they may experience as a result of this issue.”

The HPRA confirmed that the precautionary recall of a number of chemotherapy medicines has been undertaken.

The HPRA advised that, whilst there is no evidence at this point to suggest an issue with any of the medicines recalled, the patients who have received the products have been contacted by hospitals and offered a medical appointment.

It stated that an issue was identified by the manufacturer when carrying out its daily assessments of the manufacturing process using a test product.

This test product contains a substance which is used to aid in the detection of the potential presence of contamination.

This test product is not a medicine and is not given to patients. On Monday, October 12, a contamination was noted with the test product for a day on which 37 units of medicine were filled and, of which, 15 have been recovered unused during the recall.

"A contaminated test product does not automatically mean that the medicines produced are affected," according to the HPRA statement.

The test product, which is produced daily, must be incubated for 14 days to identify any contamination and, therefore, as a precaution, all units manufactured from September 29 were recalled.

“As of today, the 14-day incubation period for the test products produced up to October 2 has been completed successfully and no contamination has been found,” the HPRA stated.

“This means that 132 of a total of 297 units filled over the 14-day period are not implicated. Additionally, 45 unused units have been recovered.

“The contaminant in the single unit of test product has been identified and this information has been communicated to the hospitals concerned so that prescribers can choose the best treatment in the event of any patient presenting with infection.

“The HPRA is overseeing the recall and is continuing to investigate this incident and evaluate the manufacturer’s onsite processes. The equipment used in the manufacture of these products has been taken out of use pending completion of the investigation.”

According to the HPRA, no issues have been identified with other production equipment which are also subject to the same daily test.

UPDATE (3.44pm): The Irish Cancer Society said: "Anything which has an adverse effect on cancer patients and causes anxiety to patients and their families is of paramount concern to the Society.

"The Society is in touch with the HSE and is continuing to monitor the situation closely.

"If anyone is experiencing anxiety as a result of this, they can contact the Irish Cancer Society’s Cancer Nurseline on Freephone 1800 200 700 to speak to a nurse who can offer information and support."